MAUDE Adverse Event Report: B. Braun Avitum AG Dialog+®; KDI-Dialyzer, High Permeabilit

Catalog Number	710200L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/03/2026
Type of Reportable Event	Death
Event or Problem Description
Per customer description: customer called requesting a b.Braun technical safety inspection of a machine involved in a patient incident.The caller reported that the incident occurred on (b)(6) 2026, and involved a patient fatality.A patient death was reported, the patient died after therapy.No sample device or machine data records were made available for investigation; therefore, the assessment was based on the available information and a service report.A technical safety inspection (tsi) was performed by a b.Braun technician on the reported machine, and no malfunction or product deviation was identified.The device was found to be functioning as intended.As a general risk mitigating principle all safety-relevant functions are checked before treatment and continuously monitored during therapy.Any detected malfunction would trigger the appropriate alarm.The technical safety inspection confirmed that the machine functioned as intended.It was reported by the customer that the patient presented to the emergency department after having missed multiple dialysis treatments.Furthermore, the patient had a documented history of repeated non-attendance and missed treatment sessions.The patient also had a history of heart failure and other significant pre-existing medical risk factors.The official cause of death was reported as ventricular fibrillation.According to the information provided, the treating physician did not consider the patient's death to be related to the dialysis treatment.Based on the investigation, no product deviation was identified.The technical safety inspection confirmed that the device functioned as intended.Furthermore, there is no suspected causal relationship between the reported death and the use of the device.This conclusion is consistent with the assessment of the attending physician, who did not consider the treatment to be a related to the patient's death.Therefore, the event is considered unrelated to device performance.Consequently, the manufacturer classifies this case as not reportable to the competent authority.

• Brand Name: Dialog+®
• Common Device Name: KDI-Dialyzer, High Permeabilit
• Manufacturer (Section D): B. Braun Avitum AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• MDR Report Key: 50568067
• Report Number: 2521402-2026-00791
• Device Sequence Number: 10507261
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345(11)210907(10)090721CAD
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026
• Report Date (Section F): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 710200L
• Device Lot Number: 090721CAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2026
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown